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Long-Term Opioid Therapy in Spine Center Outpatients: Protocol for the Spinal Pain Opioid Cohort (SPOC) Study

BACKGROUND: Spinal pain is the leading cause of patient-years lived with chronic pain and disability worldwide. Although opioids are well documented as an effective short-term pain-relieving medication, more than a few weeks of treatment may result in a diminishing clinical effect as well as the dev...

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Autores principales: Manniche, Claus, Stokholm, Lonny, Ravn, Sophie L, Andersen, Tonny E, Brandt, Lars PA, Rubin, Katrine H, Schiøttz-Christensen, Berit, Andersen, Lars L, Skousgaard, Søren G
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7468635/
https://www.ncbi.nlm.nih.gov/pubmed/32663155
http://dx.doi.org/10.2196/21380
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author Manniche, Claus
Stokholm, Lonny
Ravn, Sophie L
Andersen, Tonny E
Brandt, Lars PA
Rubin, Katrine H
Schiøttz-Christensen, Berit
Andersen, Lars L
Skousgaard, Søren G
author_facet Manniche, Claus
Stokholm, Lonny
Ravn, Sophie L
Andersen, Tonny E
Brandt, Lars PA
Rubin, Katrine H
Schiøttz-Christensen, Berit
Andersen, Lars L
Skousgaard, Søren G
author_sort Manniche, Claus
collection PubMed
description BACKGROUND: Spinal pain is the leading cause of patient-years lived with chronic pain and disability worldwide. Although opioids are well documented as an effective short-term pain-relieving medication, more than a few weeks of treatment may result in a diminishing clinical effect as well as the development of addictive behavior. Despite recognition of opioid addiction in pain patients as a major problem commonly experienced in the clinic, no reference material exists on the scope of long-term problems in novel opioid users and the link to clinical outcomes. OBJECTIVE: The main aims of this study are to describe baseline and follow-up characteristics of the Spinal Pain Opioid Cohort (SPOC), to evaluate the general use of opioids in spinal pain when an acute pain episode occurs, and to demonstrate the prevalence of long-term opioid therapy (LTOT). METHODS: Prospective clinical registry data were collected from an outpatient spine center setting during 2012-2013 including patients with a new spinal pain episode lasting for more than 2 months, aged between 18 and 65 years who had their first outpatient visit in the center. Variables include demographics, clinical data collected in SpineData, the Danish National Patient Register, and The Danish National Prescription Registry. The primary outcome parameter is long-term prescription opioid use registered from 4 years before the first spine center visit to 5 years after. RESULTS: This is an ongoing survey. It is estimated that more than 8000 patients fulfill the SPOC inclusion criteria. In 2019, we began the intellectual process of identifying the most relevant supplementary data available from the wide range of existing national registries available in Denmark. We have now begun merging SpineData with relevant opioid data from Danish national registers and will continue to extract data up to 2021-2022. We will also be looking at data regarding somatic or psychiatric hospitalization patterns, patient usage of health care resources, as well as their working status and disability pensions. CONCLUSIONS: To our knowledge, this survey will be the first to document the scope of long-term problems regarding LTOT and opioid addiction following new spinal pain episodes and comparing descriptive follow-up data between substance users and nonusers. TRIAL REGISTRATION: ISRCTN Registry ISRCTN69685117; http://www.isrctn.com/ISRCTN69685117 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21380
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spelling pubmed-74686352020-09-17 Long-Term Opioid Therapy in Spine Center Outpatients: Protocol for the Spinal Pain Opioid Cohort (SPOC) Study Manniche, Claus Stokholm, Lonny Ravn, Sophie L Andersen, Tonny E Brandt, Lars PA Rubin, Katrine H Schiøttz-Christensen, Berit Andersen, Lars L Skousgaard, Søren G JMIR Res Protoc Protocol BACKGROUND: Spinal pain is the leading cause of patient-years lived with chronic pain and disability worldwide. Although opioids are well documented as an effective short-term pain-relieving medication, more than a few weeks of treatment may result in a diminishing clinical effect as well as the development of addictive behavior. Despite recognition of opioid addiction in pain patients as a major problem commonly experienced in the clinic, no reference material exists on the scope of long-term problems in novel opioid users and the link to clinical outcomes. OBJECTIVE: The main aims of this study are to describe baseline and follow-up characteristics of the Spinal Pain Opioid Cohort (SPOC), to evaluate the general use of opioids in spinal pain when an acute pain episode occurs, and to demonstrate the prevalence of long-term opioid therapy (LTOT). METHODS: Prospective clinical registry data were collected from an outpatient spine center setting during 2012-2013 including patients with a new spinal pain episode lasting for more than 2 months, aged between 18 and 65 years who had their first outpatient visit in the center. Variables include demographics, clinical data collected in SpineData, the Danish National Patient Register, and The Danish National Prescription Registry. The primary outcome parameter is long-term prescription opioid use registered from 4 years before the first spine center visit to 5 years after. RESULTS: This is an ongoing survey. It is estimated that more than 8000 patients fulfill the SPOC inclusion criteria. In 2019, we began the intellectual process of identifying the most relevant supplementary data available from the wide range of existing national registries available in Denmark. We have now begun merging SpineData with relevant opioid data from Danish national registers and will continue to extract data up to 2021-2022. We will also be looking at data regarding somatic or psychiatric hospitalization patterns, patient usage of health care resources, as well as their working status and disability pensions. CONCLUSIONS: To our knowledge, this survey will be the first to document the scope of long-term problems regarding LTOT and opioid addiction following new spinal pain episodes and comparing descriptive follow-up data between substance users and nonusers. TRIAL REGISTRATION: ISRCTN Registry ISRCTN69685117; http://www.isrctn.com/ISRCTN69685117 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21380 JMIR Publications 2020-08-19 /pmc/articles/PMC7468635/ /pubmed/32663155 http://dx.doi.org/10.2196/21380 Text en ©Claus Manniche, Lonny Stokholm, Sophie L Ravn, Tonny E Andersen, Lars PA Brandt, Katrine H Rubin, Berit Schiøttz-Christensen, Lars L Andersen, Søren G Skousgaard. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.08.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Manniche, Claus
Stokholm, Lonny
Ravn, Sophie L
Andersen, Tonny E
Brandt, Lars PA
Rubin, Katrine H
Schiøttz-Christensen, Berit
Andersen, Lars L
Skousgaard, Søren G
Long-Term Opioid Therapy in Spine Center Outpatients: Protocol for the Spinal Pain Opioid Cohort (SPOC) Study
title Long-Term Opioid Therapy in Spine Center Outpatients: Protocol for the Spinal Pain Opioid Cohort (SPOC) Study
title_full Long-Term Opioid Therapy in Spine Center Outpatients: Protocol for the Spinal Pain Opioid Cohort (SPOC) Study
title_fullStr Long-Term Opioid Therapy in Spine Center Outpatients: Protocol for the Spinal Pain Opioid Cohort (SPOC) Study
title_full_unstemmed Long-Term Opioid Therapy in Spine Center Outpatients: Protocol for the Spinal Pain Opioid Cohort (SPOC) Study
title_short Long-Term Opioid Therapy in Spine Center Outpatients: Protocol for the Spinal Pain Opioid Cohort (SPOC) Study
title_sort long-term opioid therapy in spine center outpatients: protocol for the spinal pain opioid cohort (spoc) study
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7468635/
https://www.ncbi.nlm.nih.gov/pubmed/32663155
http://dx.doi.org/10.2196/21380
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